| Device Type ID | 626 |
| Device Name | Test, Immunoassay, Biosensor, Hcg |
| Regulation Description | Human Chorionic Gonadotropin (HCG) Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1155 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NAL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 626 |
| Device | Test, Immunoassay, Biosensor, Hcg |
| Product Code | NAL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Human Chorionic Gonadotropin (HCG) Test System. |
| CFR Regulation Number | 862.1155 [🔎] |
| Device Problems | |
|---|---|
False Positive Result | 4 |
Mechanical Problem | 3 |
Incorrect Or Inadequate Test Results | 2 |
Low Test Results | 2 |
Tube | 2 |
High Test Results | 2 |
Device Displays Incorrect Message | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Syringe | 1 |
Seal | 1 |
Mixer | 1 |
Photomultiplier (PM) Tube | 1 |
| Total Device Problems | 21 |